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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031923
Receipt No. R000036462
Scientific Title Study on the effects of dietary guidance on the thinning of the endometrium
Date of disclosure of the study information 2018/03/27
Last modified on 2018/09/11

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Basic information
Public title Study on the effects of dietary guidance on the thinning of the endometrium
Acronym Study on the effects of dietary guidance on the thinning of the endometrium
Scientific Title Study on the effects of dietary guidance on the thinning of the endometrium
Scientific Title:Acronym Study on the effects of dietary guidance on the thinning of the endometrium
Region
Japan

Condition
Condition Healthy Adults
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Study the effects of dietary guidance on the thinning of the endometrium.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Endometrial thickness
Key secondary outcomes Presence / absence of pregnancy, equol production ability, subject background

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Dietary guidance
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1.Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2.Healthy Japanese who is 20 years old or more
3.Persons who' s endometrial in the implantation stage should is less than 10 mm
4.For those with normal luteal body function (blood estradiol > 100 pg / ml, progesterone > 10 mg / ml)
Key exclusion criteria 1.Persons who have chronic illness and are receiving medication
2.Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam
3.Persons who were judged as inappropriate for subjects by the principal investigator
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihiro Sakurai
Organization Medical Corporation Obstetrics and gynecology clinic SACRA
Division name President
Zip code
Address 2-9-3 Shin-ishikawa, Aoba-ku, Yokohama-shi, Kanagawa, JAPAN
TEL 045-911-9936
Email ceo@cl-sacra.com

Public contact
Name of contact person
1st name
Middle name
Last name Akihiro Sakurai
Organization Medical Corporation Obstetrics and gynecology clinic SACRA
Division name President
Zip code
Address 2-9-3 Shin-ishikawa, Aoba-ku, Yokohama-shi, Kanagawa, JAPAN
TEL 045-911-9936
Homepage URL
Email ceo@cl-sacra.com

Sponsor
Institute Healthcare Systems Co., Ltd.
Institute
Department

Funding Source
Organization Healthcare Systems Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 27 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 03 Month 26 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 27 Day
Last modified on
2018 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036462

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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